Food effect refers to food-drug interactions which lead to either a decrease or an increase of the extent of drug absorption. The commercially available capsules of doxycycline (Oracea® 40 mg capsules) for the treatment of inflammatory lesions (papules and pustules) of rosacea is a combination of immediate release (30 mg) and delayed release (10 mg) components. As per the prescribing information, the capsules have significant food effect and thus are recommended to be taken on an empty stomach, preferably at least one hour prior to or two hours after meals. The Cmax and AUC0-t of Oracea® decrease by 45% and 22% respectively when taken along with food.
Therefore, there exists a need for a pharmaceutical composition of doxycycline which is capable of reducing the food effect of doxycycline. The present inventors have developed a pharmaceutical composition of doxycycline in the form of a tablet with reduced food effect, which would enable the patient to take the drug without regard to meals, thereby improving patient convenience and compliance.